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ustekinumab (Absimky / DMB 3115 / DA3115)

✓ Approved

Meiji Seika Pharma Co., Ltd. · IL12B · Monoclonal Antibodies

What is ustekinumab?

ustekinumab is a monoclonal antibodies developed by Meiji Seika Pharma Co., Ltd.. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesAbsimky, DMB 3115, DA3115
CompanyMeiji Seika Pharma Co., Ltd.
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetIL12B, IL23A
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Meiji Seika Pharma Co., Ltd.

Mechanism of Action

Molecular Targets

ustekinumab acts on 2 molecular targets:

IL12Binterleukin 12B (CLMF2, CLMF)
IL23Ainterleukin 23 subunit alpha (P19, SGRF)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

ustekinumab is developed for 4 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
Skin and subcutaneous tissue disordersPsoriasis✓ Approved
Gastrointestinal disordersColitis ulcerative✓ Approved
Gastrointestinal disordersCrohn's disease✓ Approved
Musculoskeletal and connective tissue disordersPsoriatic arthropathy✓ Approved

Related Research Articles

PubMedDiabetologia2026-07-17

Relationship between participant-reported outcomes, residual beta cell function and metabolic parameters in youth with newly diagnosed type 1 diabetes.

Taylor Peter N PN, Cheung Wai-Yee WY, Lagorio Price Joe J, Boughton Charlotte C et al.

Clinical trials of interventions to preserve beta cell function in new-onset type 1 diabetes frequently employ participant-reported outcome measures (PROMs). However, the expected changes in PROMs scores immediately following diagnosis and their association with residual beta cell function, metabolic markers and continuous glucose monitoring (CGM) are unclear. Repeated PROMs including Paediatric Quality of Life Inventory diabetes module (PedsQL) and hypoglycaemia fear survey (HFS) were recorded from participants aged 10-18 years with newly diagnosed type 1 diabetes and their parents in two clinical trials: CLOuD (N=97, hybrid closed loop [HCL] vs multiple daily injections [MDI]) and USTEKID (N=72, ustekinumab immunotherapy vs placebo). Scores were compared with serial mixed meal-stimulated C-peptide levels (AUC C-peptide), HbA1c and CGM data. PedsQL and HFS scores for children/adolescents and their parents showed wide variation between individuals but did not change substantially within individuals over the first 48 months from diagnosis. Baseline scores were highly predictive of scores at 12-48 months (p<0.001). PedsQL scores were higher (better) in those reported by children/adolescents than by their parents (p<0.01). In contrast, HFS scores were higher in parents than children (p<0.001), indicating more fear. Strong correlations were observed between child and parent scores (p<0.001). No significant improvement in these scores was detected following intervention (ustekinumab or HCL). Meta-analysis revealed modest but statistically significant associations between HbA1c and PedsQL (β(std)=-0.11; 95% CI -0.20, -0.03) and HFS (β(std)=0.11; 95% CI 0.00, 0.21), and between CGM time in range and PedsQL (β(std)=0.14; 95% CI 0.03, 0.26) but not HFS (β(std)=-0.05; 95% CI -0.16, 0.06). Beta cell function (AUC C-peptide) was strongly associated with HbA1c (β(std)=-0.29; 95% CI -0.39, -0.20) and CGM time in range (β(std)=0.41; 95% CI 0.30, 0.52). Higher beta cell function showed a trend towards better PedsQL (β(std)=0.11; 95% CI -0.03, 0.25) and lower HFS (β(std)=-0.05; 95% CI -0.17, 0.07) but this did not reach statistical significance. PedsQL and HFS scores changed little during the first 48 months after diagnosis of type 1 diabetes. These scores showed modest but statistically significant associations with measures of glucose management (HbA1c and CGM time in range), whereas the relationships with residual beta cell function (C-peptide) were weaker and did not reach significance. The modest size of these effects suggests current PROMs capture only limited aspects of the clinical benefit associated with beta cell preservation. Future research should incorporate psychometric instruments that are specifically adapted for young people using modern diabetes technologies and undergoing disease-modifying therapy, to ensure outcomes are meaningfully represented in early-stage type 1 diabetes trials.

PMID 42467087
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PubMedThe Journal of clinical and aesthetic dermatology2026-07-16

Real-World Effectiveness and Safety of Tildrakizumab in Patients With Moderate-to-Severe Psoriasis After Failure of Ustekinumab: A Multicenter Retrospective Study.

Santos-Alarcón Sergio S, Mataix Diaz Javier J, Schneller-Pavelescu Luca L, Belinchon Isabel I et al.

To evaluate the effectiveness and safety of switching to tildrakizumab, a selective interleukin (IL) 23p19 inhibitor, in patients with moderate-to-severe plaque psoriasis who had an inadequate response to ustekinumab (IL-12/23 inhibitor) in a real-world setting. A multicenter retrospective observational study was conducted and included 14 patients who switched to tildrakizumab following ustekinumab failure. Effectiveness was assessed using Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA), and Dermatology Life Quality Index (DLQI) at Weeks 0, 12, 28, 36, and 52. The cohort (mean age: 45.92 years; 85.7% prior systemic therapy) showed rapid improvement. Mean PASI decreased from 9.36 at baseline to 2.60 at Week 12, maintaining low disease activity through Week 52 with 100% of patients achieving an absolute PASI score <3. Similar trends were observed in PGA and DLQI scores. No new safety signals were identified. This study included a small sample size (n=14) and retrospective design. Tildrakizumab showed consistent clinical improvement as a rescue therapy for patients after ustekinumab failure, supporting the clinical benefit of switching from p40 to specific p19 inhibition.

PMID 42459246
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PubMedCureus2026-07-16

Demographic Analysis of Patients With Ulcerative Colitis Undergoing Restorative Proctocolectomy With Ileal Pouch-Anal Anastomosis: A Single-Center Retrospective Study.

Pérez Queb Angel Geromin AG, Philippe Ponce Mildred M, Contreras Avilés Estefania E, Sebastian Ocampo Valeria Natalie VN et al.

Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease limited to the colonic mucosa, with rising incidence and prevalence in many regions of the world, including Latin America. A subset of patients requires colectomy for medically refractory disease, acute severe colitis, dysplasia, or malignancy, for whom restorative proctocolectomy with ileal pouch-anal anastomosis (RPC-IPAA) is the preferred restorative procedure. Pouch-related complications -- including pouchitis, chronic antibiotic-refractory pouchitis (CARP), pouch failure, and diagnostic reclassification to Crohn's disease -- represent major clinical challenges; however, published institutional data on RPC-IPAA outcomes from hospital centers in Mexico and Latin America remain exceptionally scarce. This descriptive single-center study aimed to describe the demographic profile, operative characteristics, and predefined pouch-related complications in patients with UC who underwent RPC-IPAA at a tertiary referral center in Mexico. A retrospective observational study was conducted at the Inflammatory Bowel Disease Clinic of the Coloproctology Service, Hospital General de México "Dr. Eduardo Liceaga," reviewing medical records of UC patients who underwent RPC-IPAA between 2010 and 2022. Demographic and clinical variables were analyzed using IBM SPSS Statistics, version 29 (IBM Corp., Armonk, NY). Quantitative variables were summarized as mean ± SD and categorical variables as frequencies and percentages. Pouchitis was diagnosed using the Pouchitis Disease Activity Index (PDAI ≥7). CARP was defined as active pouchitis (PDAI ≥7) persisting despite at least four consecutive weeks of antibiotic therapy and failure of at least two sequential antibiotic regimens. Postoperative follow-up was calculated from the date of pouch creation to the last clinical encounter. Fourteen patients were included; 8 (57.1%) were women. Mean age was 34.86 ± 7.94 years. All patients had Montreal E3 pancolitis. The mean interval between UC diagnosis and pouch creation was 3.86 ± 1.81 years. The median postoperative follow-up was 6.2 years (IQR: 3.4-9.1 years; range: 0.5-12.0 years). J-pouch construction was performed in 13 (92.9%) patients and D-pouch in 1 (7.1%). One (7.1%) patient experienced pouch failure and underwent W-pouch reconstruction. One (7.1%) patient originally diagnosed with UC E3 was subsequently reclassified as Crohn's disease (Montreal A2L4B2) and is currently receiving anti-interleukin-12/23 therapy (ustekinumab). Pouchitis occurred in 4 (28.6%) patients; all developed CARP and are currently being treated with anti-integrin therapy (vedolizumab). In this descriptive single-center study, RPC-IPAA was predominantly performed with J-pouch construction, achieving durable pouch preservation over a median follow-up of 6.2 years. Pouch-related complications -- including CARP, pouch failure, and diagnostic reclassification to Crohn's disease -- emerged as important sources of morbidity requiring escalation to advanced biologic therapy and, in selected cases, surgical reintervention. These findings underscore that successful pouch surgery depends on structured individualized surveillance, dedicated multidisciplinary care, and timely access to biologic therapies throughout the postoperative course.

PMID 42460217
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PubMedTherapeutic advances in gastroenterology2026-07-15

Current and novel biomarkers for predicting and assessing therapeutic response in inflammatory bowel disease: a systematic review.

Radford Shellie S, John Anoop A, Latino-Kelly Antonina A, Alexander Catherine C et al.

Despite the availability of various advanced treatments for inflammatory bowel disease (IBD), it has been impossible to predict which therapy would offer the best response to the patient. The aim of this systematic review is to explore current and novel biomarkers for predicting and assessing therapeutic response to advanced therapies presently in clinical use in IBD. A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PROSPERO ID: CRD42024559652). A systematic literature search for all primary research looking at biomarkers in predicting response to advanced therapy in Crohn's disease (CD) or ulcerative colitis (UC) was conducted across MEDLINE, EMBASE and PubMed databases. Abstracts, case studies, commentary papers and review articles were excluded. Fifty-five studies were included in this review investigating baseline predictors of response to anti-tumour necrosis factor, ustekinumab, vedolizumab and ozanimod therapies in both CD and UC. The various biomarkers studied included blood, serum, faecal, histological, nutrient, genetic and pharmacokinetic markers. C-reactive protein and faecal calprotectin were among the most commonly studied biomarkers; however, there were inconsistencies with regard to optimum cutoff values used and hence their roles as baseline predictors of response to advanced therapies are yet unclear. None of the biomarker studies to date has yet transitioned to clinical use. Biomarker identification to predict therapeutic response persists to be an ongoing challenge. Further work through large well-designed prospective cohort studies is needed to further refine the clinical utility of these tools. The protocol was prospectively registered with the PROSPERO database (CRD42024559652).

PMID 42454213
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PubMedJAMA dermatology2026-07-15

Tuberculosis-Related Outcomes in Dermatologic Patients Receiving Systemic Therapy: A Systematic Review and Meta-Analysis.

Liu Kaixuan K, Zeng Ziyi Z, Lu Wenjie W, Yang Yin Y et al.

Biologic agents are commonly used with conventional immunosuppressants for treatment of immune-mediated dermatologic diseases, raising concerns about tuberculosis (TB) risk, particularly in high-burden geographic regions. Previous studies have shown inconsistent results across biologic classes, with most focusing on active TB and limited data on latent TB infection (LTBI) conversion. To evaluate the incidence of active TB and LTBI conversion in dermatologic patients receiving systemic therapy and to explore differences by biologic class and regional TB burden. PubMed/MEDLINE, Embase, Web of Science Core Collection, and the Cochrane Library were searched from database inception to October 1, 2025. Controlled vocabulary and free-text terms were used for dermatologic diseases, systemic therapies, and tuberculosis-related outcomes. Clinical trial registries and reference lists were also screened. Randomized clinical trials, cohort studies, case-control studies, and cross-sectional studies reporting active TB or LTBI conversion in dermatologic patients receiving systemic therapy were included. Two reviewers independently screened records and performed full-text assessment. Data extraction and risk-of-bias assessment (Newcastle-Ottawa Scale and Cochrane Risk of Bias tool) were conducted independently by 2 reviewers following PRISMA guidelines. Single-arm incidence rates were pooled using random-effects models with logit transformation. Prespecified subgroup analyses were conducted by biologic class and regional TB burden. Primary outcomes were incidence of LTBI conversion (among patients with negative baseline results of tuberculin skin test or interferon-gamma release assay) and active TB during follow-up. Of 4726 records identified, 31 studies comprising a total of 15 005 patients met inclusion criteria and were included in the analysis. The pooled incidence of LTBI conversion was 4.3%, highest with tumor necrosis factor inhibitors, followed by interleukin (IL)-17 and ustekinumab (IL-12/23 p40 inhibitor). The overall incidence of active TB was 1.0% and it was more frequent in high-burden regions. In this systematic review and meta-analysis, TB-related risk varied by biologic mechanism and epidemiologic context. Risk assessment and monitoring should integrate dermatologic treatment class and regional TB burden to guide clinical decision-making.

PMID 42455533
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PubMedJournal of the European Academy of Dermatology and Venereology : JEADV2026-07-14

Switching to ustekinumab biosimilars for plaque psoriasis: A systematic review and meta-analysis.

Ghanem Laura L, Cevallos-Cueva Martin M, Kirmani Najwaa N, Aktaş Sümeyye S et al.

PMID 42447177
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